Status:
COMPLETED
SI Joint Stabilization in Long Fusion to the Pelvis
Lead Sponsor:
SI-BONE, Inc.
Conditions:
Sacroiliac Joint Disruption
Scoliosis Lumbar Region
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
Detailed Description
This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional ...
Eligibility Criteria
Inclusion
- Age 21-75 at time of screening
- Patient scheduled for multilevel (\>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
- Patient has signed study-specific informed consent form
- Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
Exclusion
- Indication for multilevel spine fusion surgery is any of the following:
- Congenital neuromuscular disease
- Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
- Grade IV spondylolisthesis
- Prior sacroiliac joint fusion/fixation on either side
- Presence of spinal cord stimulator
- Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
- Surgeon plans to use iliac screw for pelvic fixation
- Any known sacral or iliac pathology
- Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
- Known metabolic bone disease
- Severe osteoporosis
- Known allergy to titanium or titanium alloys
- Use of medications known to have detrimental effects on bone quality and soft-tissue healing
- Neurologic condition that would interfere with postoperative physical therapy
- Current local or systemic infection that raises the risk of surgery
- Patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SI joint or low back pain.
- Currently pregnant or planning pregnancy in the next 2 years
- Prisoner or a ward of the state.
- Known or suspected drug or alcohol abuse
- Uncontrolled psychiatric disease that could interfere with study participation
- Fibromyalgia
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT04062630
Start Date
May 20 2020
End Date
January 15 2025
Last Update
February 18 2025
Active Locations (31)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Scripps Hospital
La Jolla, California, United States, 92037
4
University of California, San Diego
La Jolla, California, United States, 92037